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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 10, 2026


BIOCARDIA, INC.


(Exact name of registrant as specified in its charter)



Delaware

001-38999

23-2753988


(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)



320 Soquel Way
SunnyvaleCalifornia 94085


(Address of principal executive offices and zip code)


Registrants telephone number, including area code: (650226-0120



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001
BCDA
The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐






Item 8.01
Other Events.

On February 10, 2026, BioCardia, Inc. issued a press release announcing it has completed its Pre-Submission under the Q-Submission program to the U.S. Food and Drug Administration for the approval of its Helix Transendocardial Delivery Catheter for intramyocardial therapeutic and diagnostic agent delivery.

A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

The information in this Item 8.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description
99.1

BioCardia, Inc. press release dated February 10, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)



SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


BIOCARDIA, INC.



/s/ Peter Altman, Ph.D.

Peter Altman, Ph.D.

President and Chief Executive Officer



Date: February 10, 2026